ML070390450

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Preliminary Work Product to Support Feb 13, 2007 Public Meeting - Rg 1.206 - Environmental Sections C.II.3, C.III.3, C.IV.7 and Comments
ML070390450
Person / Time
Issue date: 02/08/2007
From: William Reckley
NRC/NRO/DNRL/NGIF
To:
References
DG-1145, RG-1.206
Download: ML070390450 (23)
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Text

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments C.II.3. Environmental Report The regulatory guidance to assist prospective applicants for combined construction and operating licenses (COLs) in understanding the form and content of an environmental report (ER) is currently provided in Regulatory Guide 4.2, Preparation of Environmental Reports for Nuclear Power Stations, Rev. 2, which the NRC issued in July 1976. While this regulatory guide was structured to address the requirements of 10 CFR Part 50, as they relate to applications for construction permits and operating licenses, it remains the most comprehensive guidance for COL applicants and other stakeholders. However, the staff updated its Standard Review Plans for Environmental Review for Nuclear Power Plants, NUREG-1555, in March 2000, to recognize the alternative licensing structure under 10 CFR Part 52, and expects to update Regulatory Guide 4.2 accordingly. Regulatory Guide 4.2, Supplement 1, Preparation of Supplemental Environmental Reports for Applications to Renew Nuclear Power Pant Operating Licenses, issued in September 2000, is another valuable resource. It provides useful guidance regarding the inclusion in an application of information that was not addressed in the 1976 revision of RG 4.2, such as cumulative impacts and environmental justice.

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments C.III.3. Finality of an EIS Associated with an ESP A COL applicant may reference an early site permit (ESP). In this situation, the NRC has established a unique relationship between two major Federal actions - the ESP and COL. In addition, a COL applicant may reference a certified design or a design with a manufacturing license. Either of these approvals may contain the conclusions from an associated environmental assessment (EA) or environmental impact statement (EIS), which may be used in the COL application and considered by the NRC staff. The discussion that follows is applicable only to these special circumstances involving the referencing of an ESP, a certified design, or a manufacturing license in a COL application.

In reviewing an ESP application, the NRC staff prepares an EIS to inform the Commissions decision and disclose the environmental impacts associated with constructing and operating one or more nuclear units. Consequently, the EIS is an important starting point for preparing a COL applicants Environmental Report (ER). However, it should be noted that the EIS (and not the applicants ER) provides the basis for issuing the ESP. As such, the EIS prepared for an ESP would resolve issues within certain bounding conditions, and such issues are candidates for preclusion at the COL stage. An issue resolved in the EIS is afforded finality at the COL stage, provided that no new and significant information has become available on the issue.

By contrast, if a given environmental issue was not resolved at the ESP stage, either because sufficient information was not available to permit resolution or because the ESP applicant was permitted to defer the issue (e.g., the benefits assessment), the COL applicant must address the issue in its COL application. A COL application must also demonstrate that the design of the facility falls within the site characteristics and design parameters specified in the ESP. In addition, the COL application should indicate whether the site is compliant with the terms and conditions of the ESP.

The NRC is ultimately responsible for completing any review required to fulfill its responsibilities under the National Environmental Policy Act, for example, to ensure that the conclusions regarding a resolved ESP environmental issue remain valid for a COL action. However, the COL applicant (the proponent for the action) is expected to initially identify whether any new and significant information has become available for such an issue. Thus, a COL applicant should have a reasonable process to ensure that it becomes aware of new and significant information that may bear on the earlier NRC conclusion, and should document the results of this process in an auditable form for issues for which the COL applicant does not identify any new and significant information. Under 10 CFR 51.70(b), the NRC is required to independently evaluate and be responsible for the reliability of all information used in the EIS, including an EIS prepared for a COL application. Toward that end, the NRC staff may (1) inquire into the continued validity of information disclosed in an EIS for an ESP that is referenced in a COL application, and (2) look for any new information that may affect the assumptions, analyses, or conclusions in the ESP EIS.

The types of new information that a COL applicant must consider in preparing its ER includes any information regarding the site or design to the extent that it differs from, or is in addition to, that discussed in the ESP EIS. In the context of a COL application that references an ESP, the NRC staff defines new (in new and significant information) as any information that was both (1) not considered in preparing the ESP environmental report or EIS (as may be evidenced

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments by references in these documents, applicant responses to NRC requests for additional information, comment letters, etc.) and (2) not generally known or publicly available during the preparation of the EIS (such as information in reports, studies, and treatises). This new information may include (but is not limited to) specific design information that was not provided in the ESP application (especially where the design interacts with the environment), or information that was in the ESP application, but has changed by the time of the COL application

[for example, a change in the regional socioeconomic profile resulting from a natural event (e.g., Hurricane Katrina)]. New information may or may not also be significant.

The NRC expects the COL applicant referencing an ESP to have a reasonable auditable process with certain attributes to ensure that the applicant would become aware of new and significant information, and to describe the process in its COL ER. This process description should include (1) the methods that the COL applicant uses to ensure that it is cognizant of new information, if it exists, and (2) the process for evaluating the significance of new information, if found. Methods to ensure cognizance of new information include the following examples:

  • reviewing environmental monitoring results
  • reviewing related scientific literature
  • surveying environmental professionals familiar with the site environs (for example, the environmental and operations staff of a nearby nuclear or other industrial facility)
  • exchanging information within the industry through peer groups and industry organizations
  • consultations with academicians knowledgeable of the local environment
  • consultations with Federal, State, Tribal, and local environmental, natural resource, permitting, and land use agencies
  • verifying that the assumptions and representations made in the ESP ER are still valid
  • verifying that the NRC staffs assumptions in the ESP EIS are still valid
  • reviewing information needs in the Environmental Standard Review Plan that either were not provided for the ESP or that have changed since the ESP was issued.

The description of the process for evaluating the significance of new information should also include the organizational procedures for handling reports of new information and the criteria used to determine the applicability of such information. Detailed supporting information need not be included in the ER, but should be available in auditable form for review by the NRC staff.

Such supporting information may include the following:

  • qualifications of participants involved in the process, their organizational affiliations, how they interact among themselves, and the role they serve in the process
  • any consultations with academicians and Federal, State, Tribal, and local environmental, natural resource, permitting, and land use agencies
  • any new information identified and the assessment of its significance (with information that the applicant determines to be both new and significant submitted in the ER, as required by 10 CFR 51.50(c)(1)(iii) of the revised rule).

If the staff determines that new information that was not submitted is significant, it will have to send a request for additional information to docket the information.

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments In the past, the NRC staff has explained the relationship between the environmental review of an ESP application and that of a COL application referencing the ESP by analogy to the environmental review process for license renewal. In fact, the process described above for a COL applicant referencing an ESP is consistent with the well-established and clearly understood process for license renewal. For additional information and purposes of comparison, the attributes of the process to identify new and significant information for license renewal applications is described in Regulatory Guide 4.2, Supplement 1, Preparation of Supplemental Environmental Reports for Applications to Renew Nuclear Power Plant Operating Licenses, dated September 2000.

Similarly, for environmental matters resolved in a design certification EA or a manufacturing license EA, the COL ER should address any new and significant information regarding the site or design, to the extent that it differs from, or is in addition to, that discussed in the EA. Also, as in the earlier discussion, in the context of a COL application that references a certified design or manufacturing license, the NRC staff defines new (in new and significant information) as any information that was both (1) not considered in preparing the design certification or manufacturing license application or the related EA (as may be evidenced by references in these documents, applicant responses to NRC requests for additional information, comment letters, etc.) and (2) not generally known or publicly available during the preparation of the EA (such as information in reports, studies, and treatises). This new information may include (but is not limited to) how the design interacts with the environment, such as the actual dispersal and demographic information in the context of the bounding values considered in the EA.

Again, new information may or may not also be significant.

For matters resolved at the ESP stage or in an EA associated with a certified design or manufacturing license, if there is no new and significant information that differs from that discussed in the ESP EIS or EA, the NRC staff will rely upon (tier off) the ESP EIS or EA, and will disclose its conclusion for matters covered in the environmental review for the ESP EIS or EA. Toward that end, the COL EIS will provide a summary discussion of the NRC staffs conclusion from the ESP EIS or EA. This approach to ensure that the EIS is complete is also based on the successful methods used in the environmental review process for license renewal. Absent new and significant information, such matters will not be subject to litigation at the COL stage, even though they are included in the COL EIS.

In summary, the initial burden to assess newly identified information and issues that were deferred to the COL application falls to the COL applicant. Thus, the NRC staff expects the COL applicant to provide sufficient information to resolve any significant environmental issues that were not considered in the ESP proceeding, for either the site or the design.

In addition, the information contained in the COL application should be sufficient to aid the NRC staff in developing its independent analysis (see 10 CFR 51.45).

Regarding this last statement, an applicant for a COL that references an ESP must still provide in its ER the information that staff needs for its review (see RG 4.2 and the ESRP) that was not provided in the ESP. For example, assume that the ESRP would typically have the staff review the design of a specific system as part of its evaluation of the impacts of that system on the environment. Assume further that the design details for that system were not available at the ESP stage. Review Standard (RS)-002, Processing Applications for Early Site Permits, allowed the staff to perform its review at the ESP stage despite the missing information if it

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments could substitute its judgement or assumptions1. This approach allowed the staff to resolve a number of issues at the ESP stage which otherwise would have been unresolved. However, in the COL application referencing the ESP the staff expects the applicants ER to provide the information that was not available at the ESP stage. To do any less would be to create a disparity in the level of detail required between an ESP/COL review versus the review of a COL without an ESP. As long as the more detailed information provided in the COL application referencing an ESP is determined by the staff not to be new and significant in regards to a resolved issue, it could not be the subject of a contention admitted to the proceeding on the COL application. See 10 CFR 51.107(c).

1 Note that there is no similar dispensation for the review of a COL application.

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments C.IV.7. Pre-Application Activities The NRC staff believes that addressing certain topics with COL applicants will benefit both the staff and the applicants. The staff collectively calls these interactions pre-application activities.

Despite the inherent benefits, COL applicants are not required to engage in pre-application activities.

Pre-application activities should not focus on what can be done prior to the submission of a COL application. Rather, these interactions should focus on what would be most beneficial to the review, and what would achieve the best and most efficient use of staff and applicant resources.

Toward that end, the staff categorizes pre-application activities as (1) those that support the COL application, and (2) those that support the environmental review, as discussed in the following sections.

C.IV.7.1 Pre-Application Activities that Support the COL Application C.IV.7.1.1 COL Applications Referencing a Certified Design Pre-application activities that support a COL application referencing a certified design should focus on the following topics:

  • potential deviations from the certified design
  • process and schedule for completing inspections, tests, analyses, and acceptance criteria (ITAAC) associated with the design acceptance criteria (DAC)
  • plans for addressing COL action items in the NRCs final safety evaluation report (FSER)

C.IV.7.1.2 COL Applications Referencing an Early Site Permit Pre-application activities that support a COL applications referencing an early site permit (ESP) should focus on the following topics:

  • potential deviations from the ESP
  • plans for addressing COL action items and conditions in the permit C.IV.7.1.3 All COL Applications Pre-application activities that support a COL application should focus on the following topics (regardless of whether the application references a certified design or an ESP):
  • exemptions from the regulations (other than deviations from the certified design)
  • deviations from staff guidance
  • potential policy issues
  • fabrication schedule for long-lead-time components
  • schedule for site characterization activities
  • plans to request limited work authorization
  • plans for interfacing with other Federal, State, and local agencies and/or officials

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments

  • relationship between the COL application and other licensing activities (such as review of a design certification)

C.IV.7.2 Pre-Application Activities that Support the Environmental Review C.IV.7.2.1 Initial Interactions Pre-application activities that support the environmental review should include early and frequent discussions between the NRC and the prospective applicant. Topics should include:

  • Discuss the status of plans for the project.
  • Discuss what activities have been iniitated.
  • Discuss NRC expectations for the pre-application activities and for the application itself.

C.IV.7.2.2 Alternative Sites Pre-application activities that support the environmental review should include the following interactions related to alternative sites:

  • Review the process for selecting the alternative sites and then narrowing the selection to the proposed site.
  • Visit the proposed and alternative sites and gather reconnaissance-level information.

Identify any issues and concerns related to each site. For existing sites, the site visit may include the transmission corridors.

C.IV.7.2.3 Pre-Application Monitoring Pre-application activities that support the environmental review should include the following interactions related to pre-application monitoring:

  • Obtain information regarding the applicants monitoring-related plans, and compare those plans to the NRCs environmental standard review plan (ESRP) guidance in NUREG-1555, Standard Review Plans for Environmental Reviews for Nuclear Power Plants, to identify any apparent discrepancies.
  • Observe the applicants implementation of portions of the monitoring programs.

C.IV.7.2.4 Federal, State, Tribal, and Other Entities Pre-application activities that support the environmental review should include the following interactions related to Federal, State, Tribal, and other entities:

  • Identify the key participants among the external organizations (e.g., cognizant Federal agencies, State agencies, local government officials, etc.) at the proposed site.
  • Meet with appropriate representatives of external government organizations that have a potential role in the review process. Explain the NRCs role and process. Identify any

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments issues of concern to these organizations, as well as any likely concerns related to the permits that will be required.

  • Work through the NRCs Office of the General Counsel to establish memoranda of understanding (MOUs) with selected organizations, as appropriate.

C.IV.7.2.5 Initial Data Collection Pre-application activities that support the environmental review should include the following interactions related to initial data collection:

  • For selected areas in which data are readily available from existing sources, collect data that will be needed for the review. Examples would include many portions of the socioeconomics review, cultural resources (through the State or Tribal historic preservation officer), and threatened and endangered species (from the Fish and Wildlife Service and/or National Marine Fisheries Service).
  • As sections of the application become available, take an initial look at them on-site or at the applicants offices. Identify any inconsistencies between these sections and the ESRP.

C.IV.7.2.6 Pre-Application Public Meeting Pre-application activities that support the environmental review should include a public meeting at which the staff will explain the licensing process and opportunities for public involvement, and respond to questions from the public regarding the process. This activity addresses the entire process, both the safety and environmental reviews.

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments RG-1.206, Public Questions and Comments February 7, 2007 These are questions and comments on Sections C.II.3 and CIII.3 that were submitted by the public during the DG-1145 workshop held on April 20-21, 2006 C.II.3-1 Please explain why the NRC staff did not follow the outline of Regulatory Guide 4.2 or NUREG-1555 when issuing environmental impact statements (EISs) for the 3 lead early site permit (ESP) applications. Will this NRC staff practice continue for future ESP and combined license (COL) applications?

Wouldnt stakeholders have a better understanding if the NRCs EISs followed the same outline that the NRC staff requires for ESP and COL environmental reports (ERs)?

RESPONSE: Regulatory Guide 4.2, Standard Format and Content of Environmental Reports, and NUREG-1555, the environmental standard review plan (ESRP), are regulatory guidance documents. However, the Guide is intended for NRC stakeholders, including applicants, and the ESRP is intended for the staff. The Guide has not been updated since 1976 and, therefore, does not address more recent matters, such as severe accident mitigation design alternatives (SAMDAs), cumulative impacts, environmental justice; nevertheless, the Guide still represents an acceptable approach for submitting information in environmental reports (ERs). The ESRP was updated in 2000 and contains guidance for both ESPs and COLs.

The staff follows the environmental review guidance in NUREG-1555, the environmental standard review plan (ESRP), when conducting its environmental reviews for major Federal actions. Following the direction from the Commission, the staffs review guidance outlined in RS-002, Processing Applications for Early Site Permits, was to provide the flexibility to deal with the industrys Plant Parameter Envelope (PPE) concept and information that may not be available absent a specific design, and to reflect the Commissions direction regarding alternative energy source evaluations with ESPs subsequent to the issuance of the ESRP. Therefore, in complying with RS-002, the staff indeed departed from the ESRP in those circumstances where specific design information was not available using the PPE concept. For those ESP applications that will not utilize a PPE concept, the staff expects to maintain fidelity to the ESRP.

Regulatory Guide 4.2, presents an acceptable approach for applicants to submit environmental information sufficient for the staff to undertake its independent review and to develop its environmental impact statement (EIS). It is not the only way for an applicant to provide information, but it does provide insight regarding Page 9

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments the scope of information and the level of detail expected by the staff to determine whether the application is acceptable to establish a review schedule and to conduct the review. If the COL applicant elects to follow the guidance of Regulatory Guide 4.2 and does not reference an ESP, then the staff will find the approach acceptable. If the COL applicant elects to follow the guidance of Regulatory Guide 4.2 and reference an ESP, then the applicant need not reproduce information conforming with the Guide that was previously provided as part of the ESP application.

C.II.3-2 This section references Regulatory Guide 4.2 and recognizes it is outdated.

What is the schedule for updating the Regulatory Guide?

RESPONSE: The update of Regulatory Guide 4.2 is part of the NRCs infrastructure improvement activities. The staff has not yet determined whether resources should be invested on the update before the remaining environmental rulemakings (i.e., Table S-3, Table S-4, and alternative site reviews) are completed. If the update should be made before the rulemakings, then the staff had planned to complete the update in 2008; if the rulemakings should be completed first, the staff had planned to update the Regulatory Guide in 2010.

Based on stakeholder interest, the staff is investigating whether these schedules should be and could be accelerated.

C.II.3-3 The section references NUREG-1555 which was a valuable resource in preparing early site permit (ESP) applications. The NUREG should be updated to reflect changes associated with the non-regulated power markets of today, such as the need for power analyses. What is the schedule for updating the NUREG?

RESPONSE: The staff already recognized the changing power market when it issued NUREG-1555 in 2000; it was in a state of flux then and, while maturing, it still is today. The staff is assessing the updates that may be warranted to NUREG-1555 and expects to complete the update of all identified chapters in 2008. Each chapter of the ESRP that the staff will update will be prioritized and higher priority chapters will be updated first.

C.II.3-4 The guidance should address the staff expectations for a supplemental environmental report (ER) for combined license (COL) applications referencing an ESP. In these cases, most of the ER information would have been submitted with ESP.

RESPONSE: An applicant seeking an authorization from the Commission is required to submit environmental information to aid the Commission in fulfilling its responsibilities under the National Environmental Policy Act (NEPA); the applicant does not have a NEPA responsibility, the Commission does. As discussed above, Regulatory Guide (RG) 4.2, presents an acceptable approach for applicants to submit environmental information sufficient for the staff to Page 10

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments undertake its independent review and to develop its environmental impact statement (EIS). It is not the only way for an applicant to provide information, but it does provide insight regarding the scope of information and the level of detail expected by the staff to determine whether the application is acceptable to establish a review schedule and to conduct the review. If the COL applicant references an ESP and elects to follow the guidance of RG 4.2, then the applicant need not reproduce information conforming with the Guide that was previously provided as part of the ESP application.

For circumstances where the COL applicant references an ESP, one of the discussion topics relates to the content of the application regarding plant design information that may not have been available at the time of the ESP application and review. Pursuant to 10 CFR 51.50(c)(1), the COL environmental report (ER) need not contain information or analyses submitted to the Commission in Applicants Environmental Report - Early Site Permit Stage, or resolved in the Commissions early site permit environmental impact statement. If the specific reactor design and balance of plant information was not provided in the ESP ER and reviewed by the staff during the ESP review, then there is no record that it was resolved as part of the ESP. Issuance of an ESP includes the resolution of whether an alternative site was obviously superior to the proposed site; consequently, no information regarding site comparisons is required of a COL applicant referencing an ESP with the same intended use. Resolution of the alternative site issue is based on reconnaissance-level information that is not as detailed as necessary to approve the proposed site for a specific design.

Nevertheless, the staff did resolve issues to the extent possible in the proceeding on the ESP EIS based on the technical bases, assumptions, and analyses as it applied to the proposed site for a design that may have been characterized by a plant parameter envelope (PPE).

If there is no new information on a resolved issue during the intervening period between the ESP and the COL application referencing the ESP, then the issue is resolved for the purposes of the COL proceeding and it need not be re-evaluated in the COL ER. If there is new information on a resolved issue, then it is to be evaluated as described in the response to C.III 3-4 to determine whether it is significant; if it is not significant, then it need not be included in the COL ER, but the assessment must be retained by the applicant for audit by the NRC staff.

The focus in 51.50(c)(1) is to make clear to a COL applicant that it need not provide information and analyses in its COL application that has already been provided in the ESP ER or documented in the ESP EIS for the referenced ESP.

In preparing for the review of the first ESP applications, the staff developed Review Standard (RS)-002, Processing Applications for Early Site Permits.

Because the Commission recognized that much of the design information that would be required for a licensing review would not be available at the ESP stage, RS-002 was written to provide the staff the latitude to use judgement in place of prescriptive design detail in its review of ESP applications with the expectation Page 11

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments that such detail would be reconciled with the COL application referencing the ESP. See Attachment 3 to RS-002. There is no similar opportunity for deferral of detailed design and balance of plant information for a COL application because the environmental review must be completed with the issuance of the COL, i.e., taking the major Federal action.

The staff expects the COL application (or, in the case of a COL applicant referencing an ESP, the combination of the ESP EIS and COL application) to provide the staff with the information necessary to complete its environmental review in accordance with existing guidance (e.g., the ESRP, NUREG-1555, and RG 4.2). If the ESP action did not provide the detailed design and balance of plant information that the staff would review under the ESRP, then such information must be provided in the COL application. If the COL applicant does not reference an ESP, then this level of information must be provided.

Therefore, reliance on an incomplete record of information would create an inconsistency in the information requirements for an ESP/COL applicant versus a COL applicant. Specifically, the staff expects a COL applicant that does not reference an ESP would provide the information described in RG 4.2 so that the NRC staff can complete its independent evaluation and be responsible for the reliability of all information used in its EIS; the staff conducts its independent evaluation in accordance with the regulatory guidance in the ESRP. As outlined in RS-002, the staff cannot hold an ESP application to the same level of detail standard because an ESP application may predate the availability of detailed design and balance of plant information. The staff expects that the necessary level of detail would be available at the time the COL applicant references the ESP. If the COL applicant referencing an ESP does not attempt to reconcile the level of detail required, then the application may not be acceptable for the purposes of docketing and initiating the review.

C.II.3-5 Design certifications were issued with an environmental assessment concerning severe accident mitigation and design alternatives (SAMDA). Industry anticipates that the generic design control document (DCD) information on SAMDA would be referenced in the combined license (COL) environmental report (ER) and the staff's environmental assessment (EA) for the DCD would be referenced in the environmental impact statement (EIS) as the acceptance. Does the Staff agree that, using this approach, the DCD SAMDA information is resolved for the COL since it was incorporated by reference in the Design Certification rule?

RESPONSE: The staff agrees in part. A COL applicants ER may reference, and the staffs associated EIS may incorporate by reference, the EA associated with the design certification. However, the SAMDA analysis in the EA assumed certain site parameters and, as required by the recently revised Part 51, the applicant must demonstrate that the characteristics of its site fall within those parameters. See 10 CFR 51.50(c)(2) in the revised rule.

Page 12

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments While the SAMDA issue may be resolved for the purposes of the COL, it is a subset of the severe accident mitigation alternatives (SAMAs), which also includes procedures and training alternatives that may not have been addressed in the design certification. Portions of the SAMA issue that were not addressed in the design certification are not resolved by the certification.

C.II.3-6 Consideration of severe accident mitigation design alternatives (SAMDA) is resolved via design certification and documented in a NRC environmental assessment (EA). The staff environmental reviewers indicated that they will tier off the design certification environmental assessment to address severe accident mitigation alternatives (SAMA) in a combined license (COL) environmental impact statement (EIS). The regulations allow a COL application to reference a design certification application (10 CFR 52.55(c)). Thus, a COL application may reference a design certification application, including SAMDA evaluation, for which the NRC has not yet issued its environmental assessment. In this case, does the staff agree, and will DG-1145 make clear, that SAMDA would continue to be resolved via the design certification proceeding and that the COL application would be amended to incorporate the design certification, including the EA, when it is completed?

RESPONSE: The timing of applications and their reviews introduces a regulatory challenge if reviews and actions are not yet complete.

If the COL (or ESP) applicant at its own risk elects to reference a design not yet certified, then the SAMDA information to be provided in its COL application would still need to analyze the particular population distribution and site-specific dispersion characteristics that would otherwise be needed to conclude that it would have been bounded by that considered in the design certification SAMDA analysis.

While the SAMDA issue may be resolved for the purposes of the COL, it is a subset of the severe accident mitigation alternatives (SAMAs), which also includes procedures and training alternatives that may not have been addressed in the design certification. Portions of the SAMA issue that were not addressed in the design certification are not resolved by the certification.

C.II.3-7 The schedules for revising Regulatory Guide 4.2 and NUREG 1555 to address combined license (COL) reviews are well beyond the time frame needed for the first set of COL applications being developed. Has the Staff considered other mechanisms for updating specific portions of those documents such as the interim staff guidance previously utilized to update portions of the Review Standards such as RS-002 for Early Site Permits?

RESPONSE: The update of Regulatory Guide 4.2 is part of the NRCs infrastructure improvement activities. The staff has not yet determined whether resources should be invested on the update before the remaining environmental Page 13

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments rulemakings (i.e., Table S-3, Table S-4, and alternative site reviews) are completed. If the update should be made before the rulemakings, then the staff had planned for the end of 2008; if the rulemakings should be completed first, the staff had planned to update the Regulatory Guide in 2010. Based on stakeholder interest, the staff is investigating whether these schedules can be accelerated. A Review Standard is guidance for the staff; a Regulatory Guide is guidance for stakeholders. In updating ESRP sections, the staff will consider priorities based on the significance of changes to statutory and regulatory practices, as well as changes in the power market; staff progress updating the ESRP may preclude the need for a review standard.

C.III.3-1 In section C.III.3, the first and second sentences of the fourth paragraph contradict each other. And the second sentence in the fourth paragraph does not agree with the wording in the second paragraph which states ...it should be noted that the EIS (and not the applicants ER) provides the basis for issuing the ESP. If the environmental impact statement (EIS) provides the basis for issuing the ESP, why is there a need to consider the ESP application to determine if there is new information? When addressing new and significant information, the ESP EIS should be the only document considered in the COL applicants environmental report.

RESPONSE: This portion of the guidance has been revised to conform to the recent changes to Part 51. The changes resolve the concern raised in the first part of the comment. The staff disagrees with the final statement in the comment. The applicants ER for the ESP application will be considered, among other things, when the staff determines whether information is new. As stated in the statements of consideration for the revised rule:

The NRC staff, in the context of a combined license application that references an early site permit, has defined the term new in the phrase new and significant information as any information that was both (1) not considered in preparing the ESP environmental report or EIS (as may be evidenced by references in these documents, applicant responses to NRC requests for additional information, comment letters, etc.) and (2) not generally known or publicly available during the preparation of the EIS (such as information in reports, studies, and treatises).

C.III.3-2 Does the NRC agree that if "new" information concerning matters previously considered in the early site permit (ESP) environmental report (ER) or environmental impact statement (EIS) is determined via a "reasonable process" to be not-significant, that information and significance assessment need not be presented in the COLA ER but should be retained by the applicant in auditable form, available for NRC Staff review?

RESPONSE: As stated in the recently revised Part 51, the applicant must provide the following information, among other things, in its ER: (1) information Page 14

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments to demonstrate that the design of the facility falls within the site characteristics and design parameters specified in the early site permit; (2) information to resolve any significant environmental issue that was not resolved in the early site permit proceeding; (3) any significant new information for issues related to the impacts of construction and operation of the facility that were resolved in the early site permit proceeding; (4) a description of the process used to identify new and significant information regarding the NRCs conclusions in the early site permit environmental impact statement. The process must use a reasonable methodology for identifying such new and significant information; and (5) a demonstration that all environmental terms and conditions that have been included in the early site permit will be satisfied by the date of issuance of the combined license. If the applicant finds new information that it determines is not significant, the new information need not be submitted as part of the ER. The applicant must maintain the documentation regarding the new information and its determination regarding the significance of the information in an auditable form.

The staff will audit the applicants process and review new information that the applicant concluded was not significant. If the staff concludes that the new information is significant, the applicant will be required to submit that information on the docket.

C.III.3-3 It appears that the Staff uses a format for its environmental impact statement (EIS) that is different from that used in Regulatory Guide 4.2 and NUREG-1555.

Should the application's environmental report (ER) and the staff EIS observe the same format (table of contents). This is may be of particular value for COL applications referencing an ESP since the staff's EIS has been identified as the starting point for evaluation of new and significant information.

RESPONSE: While Regulatory Guide 4.2 (current version) may not align perfectly with the evolutionary practice in recent EISs, it still represents an acceptable approach. Should the applicant elect to present the material in an alternate fashion, then it can explain why it elected to do so, for example, to align with the ESRP or the referenced EIS. As it prepares for the future applications, the staff is also considering whether its EISs should follow the format of the ESRP.

C.III.3-4 Please respond to the seven points in NEI's letter dated September 27, 2005, including points regarding a focus on adverse environmental impacts and determining significance based on a change from small to moderate impact or moderate to large.

RESPONSE: The staff provided the industry with guidance related to the transition from an ESP to a COL in its letter to the Nuclear Energy Institute (NEI) dated July 6, 2005, and, therefore, does not plan to respond to the individual points in NEIs September 27, 2005, letter. However, the staff will respond to the specifics of the comment made on DG-1145.

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Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments The industry sought feedback on the whether a COL applicant must report new information that leads to a beneficial change in impacts from that reported in the ESP EIS. As background, after considering the technical bases, assumptions, and analyses for an environmental issue, the staff generally makes its finding and reports in a summary form in terms of an impact level category (SMALL, MODERATE or LARGE); for the most part, the impacts are adverse, but some impacts can be beneficial. If an impact level category changes from one that is adverse (whether SMALL, MODERATE or LARGE) to one that is beneficial (SMALL, MODERATE or LARGE), then it is unlikely that an applicant would have to report the new information in its COL environmental report. If the new information affects the technical bases, assumptions, or analyses on an environmental issue and that new information, by itself, results in a less adverse finding of environmental impacts, then it is unlikely that an applicant would have to report the new information in its COL environmental report. For most circumstances involving beneficial changes to environmental impacts, once an applicant has identified new information and, using a systematic process, has determined that the associated environmental impacts are less than those evaluated in the ESP EIS, no further evaluation is generally necessary. The exceptions may be (1) if the beneficial change regarding the environmental impacts on one element of an issue can offset an adverse change regarding the environmental impacts on another element or (2) if the cumulative environmental impacts on one issue involve several contributors (i.e., sources) and the new information from one source may be more beneficial since the results were reported in the ESP EIS and from another source may be more adverse; in such cases, an applicant would likely want to address both the adverse and beneficial changes in impacts and this option should not be precluded.

The regulatory guidance issue that is more germane is whether information that is new and adverse is also significant2. The Council on Environmental Quality has issued guidance in this area, recommending that the new information be evaluated in terms of both context and intensity (see, 40 CFR 1508.27).

Context relates to the settings in which the impacts occur. In general, the setting for the impacts would not be expected to change from the ESP to the COL; however, some circumstances may change during the intervening period, such as allocation of water resources. Intensity refers to the severity of the impacts. It is more likely that changes in the intensity evaluation of the new information would occur between the ESP and the COL, as such may fall out of the selection of a specific design.

The industry had initially proposed that significant be defined as a change in the impact level category from SMALL to MODERATE or LARGE, or MODERATE to LARGE. The staff agreed that information that would cause 2

Note that the search is for new and significant information, not new and significant impacts. The focus relates to information that may affect the impacts.

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Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments such a change in impact level category is certainly significant. However, the staff does not believe this should be the only test for the significance of new information. The staff has, in past meetings with stakeholders, used the example of doses to members of the public as a means to illustrate its point. For example, the annual limit for total body dose under normal operations is 5 mrem/year. Assume that the ESP applicants analysis in its application and the staffs confirmatory analysis resulted in an expected total body dose of 0.05mrem/year and that, consequently, the staff finding was summarized and the impact level category was designated as SMALL. Subsequently, for this example, when the COL applicant specifies the actual plant design in its application, assume that it determined that the total body dose would actually be 4.5 mrem/year. Following the industrys proposal, because the result is still within the regulatory limit, the COL applicant would continue to find that the impact level category associated with the 4.5 mrem/year total body dose would be SMALL; again, following this proposal, the COL applicant would not conclude that the information was both new and significant. However, the projected dose for the COL is almost two orders of magnitude greater than the dose considered in the ESP and has other attributes in terms of effects on the human environment (e.g., detriment). The staff would agree that the impact level category would still be SMALL, however, it would be difficult to argue that such an increase in the projected dose resulting from some change(s) (i.e., new information) regarding the technical bases, assumptions, and analyses was not significant. This is intended to illustrate an outlier example, but it demonstrates the rationale supporting the staffs position that it could not rely solely on a change in the impact level category for a determination that information is significant.

There is no unique bright line solution to the valuation of new information in meeting the significance test; it is not analogous to a 10 CFR 50.59 process, which uses a criterion of minimal increase that can easily be quantified. At bottom, it is not possible to preclude technical judgement in the determination of significance. Furthermore, considerable judgement was used by subject matter experts in balancing insights in summarizing findings initially to determine the impact level category.

More recently, the industry recommended that the staff consider that if there is a potential to affect the finding or conclusions of the staffs evaluation of the issue, then the new information is significant. The staff agrees that information that has the potential to change an impact level category is significant whether or not analysis eventually results in a change in the impact level category. This recent proposal aligns with the staffs position; consequently, the staff will use the following approach to maintain stability in the COL review process for applicants referencing an ESP. The new information that has the potential to affect the finding, which was based on technical bases, assumptions, or analyses will be deemed to be significant if:

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Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments

1. it causes the impact level category to change from SMALL to MODERATE or LARGE, or MODERATE to LARGE, or
2. a subject matter expert evaluating the information cannot determine whether the new information will cause the impact level category to change without detailed analysis.

This approach leads to the conclusion that new information is not significant if, by inspection by a subject matter expert, such information would not lead to a notable change in the findings. For example, this would include new information that is within the bounds of the uncertainties in the technical bases, assumptions, or analyses leading to the findings in the ESP EIS or that would have little influence on the findings and conclusions. Finally, the NRC staff remains the final decision maker with regard to the determination as to whether new information is significant.

C.III.3-5 If a combined license (COL) application cannot contain complete environmental information, what process, e.g., analogous to license conditions, will be used to facilitate issuance of the COL? For example, specific routes for new transmission lines, and thus assessment of associated environmental impacts, may not be identified until after the EIS and COL are issued.

RESPONSE: The staff expects that a reasonable representation of the project, all of its associated equipment (e.g., transmission lines) and interfaces with the environment, and the status of all authorizations, permits, licenses, etc. (other than from NRC) will be described with the application. The staff recognizes that there may be circumstances where such approvals may need to be obtained, but cannot be finalized until decisions plans mature. Some of the information to perform the environmental analyses may be business sensitive or privileged; such information may need to be generalized prior to public release. In the absence of such final approvals, the staff will establish in conjunction with the permitting authority (or on its own) the bases for the NRCs impact analyses and will need to judge that it has a reasonable expectation that final authorizations, permits, licenses, etc. (other than from NRC) can be obtained. If the final approvals depart from those described in the Final EIS prior to the issuance of the COL, then the NRC will determine whether the EIS must be supplemented.

If the COL has been issued, then, based on the significance of the departure from the earlier analyses, the NRC will need to determine whether safety or security issues require that the COL be amended.

C.III.3-6 In paragraph 3, the phrase "reasonable process to ensure that it (applicant) becomes aware of 'new and significant' information" is used. Page C.III.3-2 provides guidance on the nature of the reasonable process. This guidance appears to be based on Regulatory Guide 4.2 Supp. 1. In the 3rd paragraph on page C.III.3-2, the reader is directed to Regulatory Guide 4.2 Supp 1 for additional information on the attributes of the process. Yet, the guidance now Page 18

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments provided in C.III.3 appears to contain the essential material from Position B.5.

This reference to Regulatory Guide 4.2 Supp. 1 appears unnecessary.

RESPONSE: The staff was directed by the Commission to provide insight on the attributes of an acceptable process for an applicant to determine whether new and significant information may exist on a previously resolved issue. The staff has attempted to articulate the analogous process that has been successfully implemented in the license renewal arena. While subtle differences exist, the staff believes that it is necessary for all stakeholders to recognize that this description is consistent with a well-established process and those unfamiliar with the concept can observe or be informed by its implementation elsewhere.

C.III.3-7 Section C.III.3 describes the NRCs expectations of combined license (COL) applicants regarding processes for the awareness of new information and evaluating its significance. Please identify the process that the NRC staff will use in these two areas. Will NRC staff reviews be conducted during pre-application or only after COL application receipt? Will the results of the NRCs ongoing reviews, information exchanges, consultations, etc. be made available to stakeholders prior to COL EIS issuance?

RESPONSE: First, the July 6, 2005, correspondence outlines the NRCs intended practice and discusses the similar approach used for license renewal environmental reviews for approximately 25 EISs to date. NRC does not plan to depart from these practices. NUREG-1555 and Regulatory Guide 4.2, Supplement 1, are important resources.

While the NRC staff plans to observe activities during the pre-application phase, the staff will not make any determinations regarding the adequacy of an applicants approach or its effectiveness in preparing its application until the application is received. The pre-application activities are intended to (1) familiarize the NRC team with the activities conducted by the applicant prior to receipt of the application, (2) ensure that the NRC staff is aware of the interactions made with other stakeholders and their views on environmental issues, and (3) ensure that the applicant is aware of NRC expectations of a full and complete application.

Pre-application activities will be documented in trip reports, records of communications, and summaries of information collected and will be placed in the NRC ADAMS. Numerous activities will be conducted prior to the preparation of a draft and final EIS; appropriate documentation will be included in the NRCs ADAMS system.

C.III.3-8 In section C.III.3, the second to last paragraph states, ...Toward that end, the COL EIS will provide a summary discussion of the NRC staffs conclusion from the ESP EIS or EA. This approach is to ensure that the EIS is complete...

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Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments Please confirm that this approach of providing a summary discussion is also acceptable for the applicant in the COL application environment report (ER).

RESPONSE: The discussion that follows is addressed to issues that were resolved in the ESP proceeding and for which the applicant for a COL referencing the ESP does not find any information that is both new and significant. The staff would consider the inclusion in the ER of the staffs conclusion from the ESP EIS or EA to be one part of what an applicant should include in its ER. The applicant must also include as a minimum a statement that it had searched for new and significant information and the applicants conclusion that there was no new and significant information. This will be sufficient for the ER because the applicant will also have to provide in the ER a description of the process used to identify new and significant information regarding the NRCs conclusions in the early site permit environmental impact statement. The process must use a reasonable methodology for identifying such new and significant information. See 10 CFR 51.50(c)(1)(iv). See also Regulatory Guide 4.2, Supplement 1, which explains how applicants for license renewal are expected to address the search for new and significant information and the results of that search.

C.III.3-9 Staff members indicated during the workshop that they will need sufficient information presented in the combined license (COL) application to determine that each bounding analysis in the early site permit (ESP) is bounding for the selected plant design. 52.79(a)(1) requires that the application "demonstrate that the design of the facility falls within the parameters specified in the early site permit.". To date, the parameters to be specified in the early site permit have not been identified. DG-1145 should identify how the specific parameters can be identified if the ESP has not been issued at the time of COL application.

RESPONSE: Under the revised rule, the requirements for a combined license application referencing an early site permit are at 10 CFR 51.50(c). The applicants ER must provide, among other things, (1) information to demonstrate that the design of the facility falls within the site characteristics and design parameters specified in the early site permit; (2) information to resolve any significant environmental issue that was not resolved in the early site permit proceeding; (3) any significant new information for issues related to the impacts of construction and operation of the facility that were resolved in the early site permit proceeding; (4) a description of the process used to identify new and significant information regarding the NRCs conclusions in the early site permit environmental impact statement; and (5) a demonstration that all environmental terms and conditions that have been included in the early site permit will be satisfied by the date of issuance of the combined license. If an applicant decides to submit its COL application before the ESP EIS is completed or before the ESP is issued, it does so at risk. The staff cannot state with certainty what issues will be included in the final list in the ESP that the COL applicant would have to address. However, the draft EIS (and the final EIS if published) would contain a Page 20

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments list that the staff would expect to come close to the final list in the ESP. See, for example, Appendix J in the final Clinton and North Anna ESP EISs.

C.III.3-10 During the workshop, the staff indicated that not all information provided in early site permit (ESP) environmental reports (ERs) is utilized and that the information does not need to be provided in the combined license (COL) application ER.

Can the staff provide a listing of information that has been provided in ESP ERs and not utilized? This information could be eliminated from the ESP ERs and result in better utilization of both Staff and applicant resources.

RESPONSE: The type of information provided by the three ESP applicants using the PPE concept that may not have been considered by the staff does vary.

However, the fact that the staff did not utilize the information does not equate to information that could be eliminated from the ESP ERs and the EISs.

A good example of this is the treatment of the fuel cycle impacts. The applicants presented their analyses. However, the staff found it to be incomplete even after responses to requests for additional information. The NRC staff had to reframe the analyses necessary to make its conclusions for the variety of LWR designs.

The applicants sought finality for other-than-LWRs as well, but it did not provide sufficient information to achieve that goal. Such information could be eliminated if ESP applicants choose not to seek approval for other-than-LWRs.

C.III.3-11 The staff indicated during the workshop, that all new-since-ESP environmental information must be submitted with the combined license (COL) environmental report (ER) so that the staff can determine its significance. 52.79(a)(1) states that "----the application need not contain information or analyses submitted to the Commission in connection with the early site permit, but must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the design of the facility falls within the parameters specified in the early site permit, and to resolve any other significant environmental issue not considered in any previous proceeding -----" (emphasis added). The intent is that only the new and significant information needs to be provided. This is consistent with the practice under License Renewal. Please explain the basis for the staff's view that COL applications must identify all new-since-ESP environmental information.

RESPONSE: In the final rule, an applicant for a COL referencing an ESP must provide in its ER any significant new information for issues related to the impacts of construction and operation of the facility that were resolved in the early site permit proceeding. As discussed in the statements of consideration for the rule, a COL applicant should have a reasonable process to ensure it becomes aware of new and significant information that may have a bearing on the earlier NRC conclusion. Documentation related to the applicants search for new information and its determination about the significance of the new information should be maintained in an auditable form by the applicant. The Page 21

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments NRC staff will verify that the applicants process for identifying significant new information is effective. If, during or after the audit, the staff concludes that new information is significant, the applicant will be required to submit that information on the docket.

C.III.3-12 During the workshop, the staff stated that the information in a July 6, 2005 letter is the staff's position on combined license (COL) environmental report (ER) content and that the September 27, 2005 NEI letter appeared to interpret the staffs position. Industry stated that the September 27, 2005 letter was intended to explain the industry's understanding of the staff's position. This subject should be discussed further at a later meeting.

RESPONSE: The staff expressed it willingness to continue to discuss this issue.

The staff also indicated that elements of the July 6, 2005, letter were included in the March 13, 2006, re-proposed rule.

C.III.3-13 Transmission line routings for a proposed facility will likely not be finalized when a combined license (COL) application is filed or even when the license is issued.

The COL environmental impact statement (EIS) should address the impacts of transmission line routes. Guidance should be provided on what should be included in the application and whether or not a license condition may be used for this and other unresolved environmental issues.

RESPONSE: See the response to C.III.3-5, above.

C.III.3-14 The staff indicated during the workshop that the combined license (COL) environmental report (ER) must contain environmental information that was not submitted previously for an early site permit (ESP), including specific design information in areas, such as the cooling water intake structure, where environmental impacts were addressed for ESP based on more general or typical design information and enveloping design parameters. A central principal of the plant parameter envelope approach for ESP is that environmental impacts thus concluded for ESP envelope those for a specific plant design whose characteristics fall within the site characteristics and design parameters on which the ESP is based. COL applications must demonstrate that the actual proposed facility falls within the ESP site characteristics and design parameters. Please explain why and the regulatory basis for the staff view that COL applications must contain specific design information in areas where environmental impacts were concluded for ESP on the basis of enveloping design information.

RESPONSE: As stated in the comment, COL applications must demonstrate that the actual proposed facility falls within the ESP site characteristics and design parameters. A key word in this statement is demonstrate. It isnt simply a matter of an applicant stating that its actual plant falls within the site characteristics and design parameters in the ESP. There must be a Page 22

Preliminary Work Product to Support February 13, 2007, Public Meeting Environmental Sections (C.II.3, C.III.3, and C.IV.7) and Responses to Comments demonstration that this is the case. For example, assume that the staff evaluated the impacts to aquatic biota from the plants discharge structure based on plant parameter values for discharge temperature and chemical constituents.

In the COL application the staff would expect the applicant to provide the actual design information for the plant (e.g., cooling tower design information relevant to discharge temperature, system design and operating information relevant to chemical discharges) in order to demonstrate that it meets the design parameters in the ESP.

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